Improved lead configuration for an atrial defibrillator

ABSTRACT

An implantable atrial defibrillator provides a pulse of defibrillating electrical energy to the atria of the heart in synchronism with sensed R waves in response to non-coincident sensing of an R wave at first and second areas of the heart. The defibrillating pulse is provided after a predetermined number of consecutive R waves are non-coincidently sensed to assure reliable synchronization. The atrial defibrillator is also operational in a marker mode wherein a number of synchronization marker pulses are delivered to the heart for detection on an externally generated electrocardiogram. The atrial fibrillation detector of the defibrillator is normally disabled and is activated when the sensed ventricular activity indicates a probability of atrial fibrillation to conserve a depletable power source. An endocardial lead is also described which ensures that the delivered atrial defibrillating electrical energy is substantially confined to the atria of the heart.

This is a divisional of copending application Ser. No. 07/685,130 filedApr. 12, 1991, now U.S. Pat. No. 5,282,837.

BACKGROUND OF THE INVENTION

The present invention generally relates to an atrial defibrillator fordelivering a pulse of defibrillating electrical energy to the atria of ahuman heart. The present invention is more particularly directed to afully automatic implantable atrial defibrillator which exhibits reducedpower consumption, reliable synchronized delivery of defibrillatingelectrical energy to the atria, and multiple modes of operationincluding bradycardia pacing. The present invention is further directedto an improved endocardial lead for delivering the defibrillatingelectrical energy to the atria while minimizing the electrical energyapplied to the ventricles.

Atrial fibrillation is probably the most common cardiac arrythmia.Although it is not usually a life threatening arrhythmia, it isassociated with strokes thought to be caused by blood clots forming inareas of stagnant blood flow as a result of prolonged atrialfibrillation. In addition, patients afflicted with atrial fibrillationgenerally experience palpitations of the heart and may even experiencedizziness or even loss of consciousness.

Atrial fibrillation occurs suddenly and many times can only be correctedby a discharge of electrical energy to the heart through the skin of thepatient by way of an external defibrillator of the type well known inthe art. This treatment is commonly referred to as synchronizedcardioversion and, as its name implies, involves applying electricaldefibrillating energy to the heart in synchronism with a detectedelectrical activation (R wave) of the heart. The treatment is verypainful and, unfortunately, most often only results in temporary relieffor patients, lasting but a few weeks.

Drugs are available for reducing the incidence of atrial fibrillation.However, these drugs have many side effects and many patients areresistent to them which greatly reduces their therapeutic effect.

Implantable atrial defibrillators have been proposed to provide patientssuffering from occurrences of atrial fibrillation with relief.Unfortunately, to date, none of these atrial defibrillators have becomea commercial reality to the detriment of such patients.

Implantable atrial defibrillators proposed in the past have exhibited anumber of disadvantages which probably has been the cause of thesedefibrillators from becoming a commercial reality. Two suchdefibrillators, although represented as being implantable, were notfully automatic, requiring human interaction for cardioverting ordefibrillating the heart. Both of these defibrillators require thepatient to recognize the symptoms of atrial fibrillation with onedefibrillator requiring a visit to a physician to activate thedefibrillator and the other defibrillator requiring the patient toactivate the defibrillator from external to the patient's skin with amagnet.

Synchronizing the delivery of the defibrillating or cardioverting energywith an electrical activation (R wave) of the heart is important toprevent ventricular fibrillation. Ventricular fibrillation is a fatalarrythmia which can be caused by electrical energy being delivered tothe heart at the wrong time in the cardiac cycle, such as during the Twave of the cycle. As a result, it is most desirable to sense electricalactivations of the heart to generate synchronization pulses (or signals)in a manner which avoids detecting noise as an electrical activation.Unfortunately, implantable atrial defibrillators proposed to date havenot provided either such noise immunity or any other means for assuringreliable synchronization.

Another measure for reducing the risk of inducing ventricularfibrillation during the delivery of defibrillating electrical energy tothe atria of the heart is to reduce the amount of the electrical energywhich is passed through the ventricles. In other words, it isadvantageous to confine the electrical energy to the atria as much aspossible.

Implantable defibrillators, in general, must be powered by a portable,depletable power sources, such as a battery. However, an automaticimplantable atrial defibrillator which continuously monitors atrialactivity of the heart and which continuously monitors for atrialfibrillation will consume so much power that frequent batteryreplacement, requiring explanting the defibrillator, would be necessary.

The atrial defibrillator of the present invention provides solutions toall of the above noted deficiencies in atrial defibrillators proposed todate and other features which obviate potential problems in implantableatrial defibrillators. In general, the atrial defibrillator of thepresent invention is fully automatic and provides reliablesynchronization to electrical activations, both through noise immuneelectrical activation sensing and through a test mode which permits aphysician to confirm reliable electrical activation sensing. The atrialdefibrillator of the present invention also provides for conservingbattery power by activating the atrial fibrillation detector only whenthe ventricular rate indicates a probability of atrial fibrillation. Inaddition, the atrial defibrillator of the present invention provides anew and improved endocardial lead and a method for using the same whichassures that the delivered electrical energy is confined to the atriaand little of the electrical energy is passed through the ventricles.

SUMMARY OF THE INVENTION

The present invention provides an atrial defibrillator for applying anelectrical defibrillating pulse to the atria of a human heart, whereinthe atrial defibrillator is arranged to apply the electricaldefibrillating pulse to the atria in synchronism with depolarizationactivation waves, and includes first means for sensing depolarizationactivation waves at a first area of the heart and second means forsensing the depolarization activation waves at a second area of theheart. The atrial defibrillator further includes means for detectingnon-coincident sensing of a depolarization activation wave at the firstarea of the heart by the first means and at the second area of the heartby the second means, storage means for storing electrical energy, anddelivery means coupled to the storage means and being responsive to thenon-coincident sensing of a depolarization activation wave at the firstand second areas of the heart for applying a predetermined amount of thestored electrical energy to the atria.

The present invention further provides an implantable atrialcardioverter arranged to be powered by a depletable power source fordelivering electrical energy to the atria of a human heart in need ofcardioversion. The atrial cardioverter includes sensing means forsensing electrical activations of the heart, wherein the sensing meansis continuously operable, means responsive to the sensing means fordetermining the time intervals between the sensed electricalactivations, and atrial arrythmia detector means for detecting thepresence of an atrial arrythmia of the heart. The atrial arrythmiadetecting means is normally disabled to avoid excessive consumption ofthe depletable power source. The atrial cardioverter further includesenable means for enabling the atrial arrythmia detector means responsiveto the determined time intervals and delivery means responsive to theatrial arrythmia detector means for delivering the electrical energy tothe atria of the heart in response to the atrial arrythmia detectormeans detecting an atrial arrythmia of the heart.

The present invention further provides an atrial defibrillator arrangedto be implanted beneath the skin of a patient for applying electricalenergy to the atria of a human heart. The atrial defibrillator includessensing means for sensing electrical activations of the heart, firstdelivery means for delivering a first quantity of electrical energy tothe atria of the heart in synchronism with one of the sensed electricalactivations for cardioverting the heart, second delivery means fordelivering at least one pulse of electrical energy to the heart insynchronism with one of the sensed electrical activations, wherein thepulse of electrical energy is of insufficient quantity to cardiovert theheart so as to be detected on an electrocardiogram generated externallyto the skin of the patient, and select means for selecting either thefirst delivery means or the second delivery means.

The present invention further provides an atrial defibrillator forapplying an electrical defibrillating pulse to the atria of a humanheart in synchronism with an electrical activation of the heart. Theatrial defibrillator includes sensing means for sensing electricalactivations of the heart, synchronizing pulse generating meansresponsive to the sensing means for generating a synchronizing pulse foreach sensed electrical activation, and counting means for counting thesynchronizing pulses provided by the synchronizing pulse generatingmeans. The atrial defibrillator also includes delivery means responsiveto the counting means for applying the electrical defibrillating pulseto the atria after a predetermined number of the synchronizing pulseshave been counted by the counter means and in response to the last oneof the predetermined number of synchronizing pulses.

The present invention further provides an intravascular lead for use inassociation with an atrial defibrillator of the type arranged tocardiovert the atria of the human heart. The lead includes a distal endand a proximal end, the proximal end including connector means arrangedto be received by the atrial defibrillator, and wherein the connectormeans includes first, second, and third contacts. The lead furtherincludes a first electrode at the distal end, a second electrodeproximal to the first electrode, and a third electrode proximal to thesecond electrode. The lead, further includes conductor means forelectrically connecting the first contact to the first electrode, thesecond contact to the second electrode, and the third contact to thethird electrode and the lead being flexible so as to be arranged to bepassed down the superior vena cava of the heart, into the right atrium,into the coronary sinus ostium, and advanced into the coronary sinus ofthe heart near the left side thereof. The electrodes are spaced apartsuch that when the first electrode is within the coronary sinus adjacentthe left ventricle, the second electrode is beneath the left atrium nearthe left ventricle and the third electrode is within the right atrium orthe superior vena cava.

The present invention further provides an implantable atrialdefibrillator for applying an electrical defibrillating pulse to theatria of a human heart. The atrial defibrillator includes first meansfor sensing electrical activations of the heart at the right ventricle,second means for sensing electrical activations of the heart at the leftventricle, and enable means responsive to the first means for detectingan abnormal rhythm of the right ventricle and providing an enablecontrol signal. The atrial defibrillator further includes atrialfibrillation detector means including atrial sensing means for sensingatrial activity of at least one of the atria, the atrial fibrillationdetector means being arranged to be activated by the enable controlsignal for detecting atrial fibrillation of the heart, and storage meansfor storing the electrical energy responsive to the atrial fibrillationdetector means detecting atrial fibrillation. The atrial defibrillatorfurther includes delivery means responsive to the atrial fibrillationdetector means, coupled to the storage means, and being responsive tonon-coincident sensing of an electrical activation by said first andsecond means for applying a predetermined amount of the storedelectrical energy to the atria of the heart.

The present invention further provides a method of applying electricaldefibrillating energy to the atria of a human heart while minimizing theelectrical energy applied to the right and left ventricles. The methodincludes the steps of providing a first electrode, establishingelectrical contact between the first electrode and point within thecoronary sinus beneath the left atrium, providing a second electrode,establishing electrical contact between the second electrode and aregion adjacent to the right atrium, and applying defibrillatingelectrical energy between the first and second electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawing, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is a schematic block diagram of a fully implantable atrialdefibrillator embodying the present invention for applyingdefibrillating electrical energy to the atria of a human heart and whichis shown in association with a human heart in need of atrialfibrillation monitoring and potential cardioversion of the atria;

FIG. 2 is a flow diagram illustrating the manner in which the atrialdefibrillator of FIG. 1 may be implemented in accordance with thepresent invention for providing bradycardia pacing of the rightventricle of the heart and for determining and storing the timeintervals between depolarizations of the right ventricle;

FIG. 3 is a flow diagram illustrating the manner in which the atrialdefibrillator of FIG. 1 may be implemented in accordance with thepresent invention for enabling the atrial fibrillation detector of theatrial defibrillator;

FIG. 4 is a flow diagram illustrating the manner in which the atrialdefibrillator of FIG. 1 may be implemented in accordance with thepresent invention for detecting atrial fibrillation and enabling eitherthe atrial defibrillating output or the right ventricle marker pulseoutput;

FIG. 5 is a flow diagram illustrating the manner in which the atrialdefibrillator of FIG. 1 may be implemented in accordance with thepresent invention for providing right ventricle marker pulses insynchronism with detected electrical activations (R waves) of the heart;

FIG. 6 is a flow diagram illustrating the manner in which the atrialdefibrillator of FIG. 1 may be implemented in accordance with thepresent invention for providing defibrillating electrical energy to theatria of the heart in synchronism with detected electrical activations(R waves) of the heart;

FIG. 7 is a top plan view illustrating an endocardial lead embodying thepresent invention having a plurality of electrodes for sensingelectrical activations of the left ventricle, sensing electricalactivations of the atria, and applying defibrillating electrical energyto the atria; and

FIG. 8 is a cross-sectional view, to an enlarged scale, taken alonglines 8--8 of FIG. 7.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, it illustrates a fully implantable atrialdefibrillator 30 embodying the present invention shown in associationwith a schematically illustrated human heart 10 in need of atrialfibrillation monitoring and potential cardioversion of the atria. Theportions of the heart 10 illustrated in FIG. 1 are the right ventricle12, the left ventricle 14, the right atrium 16, the left atrium 18, thesuperior vena cava 20, the coronary sinus 22, the coronary sinus ostiumor opening 24, the left ventricular free wall 26 and the inferior venacava 27. In addition, as used herein, the term "electrical activations"denotes R waves of the heart cardiac cycle which induce depolarizationsof the ventricles 12 and 14.

The atrial defibrillator 30 generally includes an enclosure 32 forhermetically sealing the internal circuit elements of the atrialdefibrillator to be described hereinafter, an endocardial first lead 34,and an intravascular second lead 36. The enclosure 32 and first andsecond leads 34 and 36 are arranged to be implanted beneath the skin ofa patient so as to render the atrial defibrillator 30 fully implantable.

The endocardial first lead 34 preferably comprises a endocardialbi-polar lead having electrodes 38 and 40 arranged for establishingelectrical contact with the right ventricle 12 of the heart 10. Theelectrodes 38 and 40 permit bi-polar sensing of electrical activationsin the right ventricle. As illustrated, the lead 34 is fed through theinferior vena cava 27, into the right atrium 16, and then into the rightventricle 12 as illustrated. As will be appreciated by those skilled inthe art, a second path for lead 34 could alternatively be through thesuperior vena cava 20, into the right atrium 16, and then into the rightventricle 12.

The second lead 36, which will be described in greater detail withrespect to FIGS. 7 and 8, generally includes a first or tip electrode42, a second or ring electrode 44, and a third electrode 46. Asillustrated, the second lead 36 is flexible and arranged to be passeddown the superior vena cava 20, into the right atrium 16, into thecoronary sinus ostium 24, and advanced into the coronary sinus 22 of theheart near the left side thereof so that the first or tip electrode 42is within the coronary sinus adjacent the left ventricle 14. Theelectrodes 42, 44, and 46 are spaced apart such that when the firstelectrode 42 is within the coronary sinus 22 adjacent the left ventricle14, the second electrode 44 is beneath the left atrium 18 near the leftventricle 14 and the third electrode 46 is in a region adjacent to theright atrium coronary sinus ostium 24 within either the right atrium 16or the superior vena cava 20. The first electrode 42 and the secondelectrode 44 enable bi-polar sensing of electrical activations of theleft ventricle 14. The second electrode 44 together with the thirdelectrode 46 provide bi-polar sensing of heart activity in the atria 16and 18. The second electrode 44 and the third electrode 46 furtherprovide for the delivery of defibrillating electrical energy of theatria. Because the second electrode 44 is located beneath the leftatrium 18 near the left ventricle 14 and the third electrode 46 iswithin either the right atrium 16 or the superior vena cava 20 and abovethe coronary sinus ostium 24, the electrical energy applied betweenthese electrodes will be substantially confined to the atria 16 and 18of the heart 10. As a result, the electrical energy applied to the rightventricle 12 and left ventricle 14 when the atria are cardioverted ordefibrillated will be minimized. This greatly reduces the potential forventricular fibrillation of the heart to be induced as a result of theapplication of defibrillating electrical energy of the atria of theheart.

Within the enclosure 32, the atrial defibrillator 30 includes a firstsense amplifier 50, a second sense amplifier 52, and a third senseamplifier 54. The first sense amplifier 50 forms a first sensing meanswhich together with the first lead 34 to which it is coupled, senseselectrical activations of the right ventricle 12. The second senseamplifier 52 forms a second sensing means which, together with the firstelectrode 42 and second electrode 44 of the second lead 36 to which itis coupled senses electrical activations of the left ventricle 14. Thethird sense amplifier 54 forms atrial sense means which, together withthe second electrode 44 and third electrode 46 of the second lead 36 towhich it is coupled senses atrial activity of the heart when enabled aswill be described hereinafter.

The outputs of the first and second sense amplifiers 50 and 52 arecoupled to first and second R wave detectors 56 and 58 respectively.Each of the R wave detectors 56 and 58 is of the type well known in theart which provides an output pulse upon the occurrence of an R wavebeing sensed during a cardiac cycle of the heart. The output of thethird sense amplifier 54 is coupled to an analog to digital converter 60which converts the analog signal representative of the atrial activityof the heart being sensed to digital samples for processing when theanalog to digital converter 60 is enabled also in a manner to bedescribed hereinafter.

The enclosure 32 of the atrial defibrillator 30 further includes amicroprocessor 62. The microprocessor 62 is preferably implemented in amanner to be described hereinafter with respect to the flow diagrams ofFIGS. 2 through 6. The implementation of the microprocessor 62 resultsin a plurality of functional stages. The stages include a first timer64, a second timer 66, a third timer 68, a synchronization markercontroller 70, and a synchronization detector 72. The functional stagesof the microprocessor 62 further include a calculator stage including anaverage calculation stage 74, a standard deviation calculation stage 76,an enable stage 78, a disable stage 80, an atrial arrythmia detector inthe form of an atrial fibrillation detector 82, a first counter 84, asecond counter 86, a third counter 88, and a charge delivery and energycontrol stage 90.

The microprocessor 62 is arranged to operate in conjunction with amemory 92. The memory 92 is coupled to the microprocessor 62 by amultiple-bit address bus 94 and a bi-directional multiple-bit databus96. The address bus 94 permits the microprocessor 62 to address desiredmemory locations within the memory 92 for executing write or readoperations. During a write operation, the microprocessor stores data,such as time intervals or operating parameters in the memory 92 at theaddresses defined by the multiple-bit addresses conveyed over bus 94 andcoveys the data to the memory 92 over the multiple-bit bus 96. During aread operation, the microprocessor 62 obtains data from the memory 92from the storage locations identified by the multiple-bit addressesprovided over bus 94 and receives the data from the memory 92 over thebi-directional bus 96.

For entering operating parameters into the memory 92, the microprocessor62 receives programmable operating parameters from an externalcontroller 100 which is external to the skin of the patient. Theexternal controller 100 is arranged to communicate with areceiver/transmitter 102 which is coupled to the microprocessor 62 overa bi-directional bus 104. The receiver/transmitter 102 may be of thetype well known in the art for conveying various information which itobtains from the microprocessor 62 to the external controller 100 or forreceiving programming parameters from the external controller 100 whichthe receiver/transmitter 102 then conveys to the microprocessor 62 forstorage in the memory 92. To that end, the memory 92 includes a modeselection portion 98 for storing mode selection information to bedescribed hereinafter.

The receiver/transmitter 102 includes a transmitting coil 106 so thatthe receiver/transmitter 102 and coil 106 form a communication means.Such communication means are well known in the art and may be utilizedas noted above for receiving commands from external to the implantableenclosures 32 and for transmitting data to the external controller 100from the implanted enclosure 32. One such communication system isdisclosed, for example, in U.S. Pat. No. 4,586,508.

To complete the identification of the various structural elements withinthe enclosure 32, the atrial defibrillator 30 further includes a paceroutput stage 108. As will be seen hereinafter, the pacer output stage108 applies stimulating pulses to the right ventricle 12 of the heart 10when bradycardia pacing is required or synchronization marker pulses tothe right ventricle when the atrial defibrillator is in the marker pulsemode. The atrial defibrillator 30 further includes a charger and storagecapacitor circuit 110 of the type well known in the art which charges astorage capacitor to a predetermined voltage level and a dischargecircuit 112 for discharging the storage capacitor within circuit 110 bya predetermined amount to provide a controlled discharge output ofelectrical energy when required to the atria of the heart. To that end,the discharge circuit 112 is coupled to the second electrode 44 and thethird electrode 46 of the second lead 36 for applying the cardiovertingor defibrillating electrical energy to the atria. Lastly, thedefibrillator 30 includes a depletable power source 114, such a lithiumbattery, for providing power to the electrical components of the atrialdefibrillator 30. As will be seen hereinafter, the atrial defibrillator30 is arranged to minimize the power consumption of the battery 114 soas to extend the useful life of the atrial defibrillator 30.

The operation of the atrial defibrillator 30 and more particularly theoperation of the functional stages residing within the enclosure 32 willnow be described with reference to the flow diagrams of FIGS. 2-6.Referring now to FIG. 2, it illustrates the manner in which the atrialdefibrillator 30 may be implemented in accordance with the presentinvention for providing bradycardia pacing of the right ventricle 12 ofthe heart 10 and the determining of the time intervals betweenelectrical activations of the right ventricle or bradycardia pacingpulses of the right ventricle. This process begins with the resetting ofthe first timer 64 in step 120. The microprocessor then, in step 122,determines whether an R wave has been detected at the right ventricle.If an R wave has not been detected at the right ventricle, the processorthen determines in step 124 if the first timer 64 has expired. If thefirst timer 64 has not expired, the processor returns to step 122 todetermine whether an R wave has been detected at the right ventricle. Ifan R wave or electrical activation has been detected at the rightventricle, the processor then in step 123 determines the time (T) sincethe first timer 64 was last reset and stores that time interval in thememory 92. The processor then returns to step 120 to reset the firsttimer 64.

If in step 124 the processor had determined that the first timer 64 hadexpired, it would proceed to step 126 to pace the right ventricle. In sodoing, the microprocessor activates the pacer output 108 and causes thepacer output 108 to provide an electrical stimulating pulse to theelectrodes 38 and 40 of the first lead 34. The timeout time of the firsttimer 64 may be, for example, one second and may be programmed into thememory 92 through the external controller 100 and thereceiver/transmitter 102.

Upon the pacing of the right ventricle in step 126, the processor thenin step 128 determines the time on the first timer 64 and stores thattime as a determined time interval. The processor then returns to step120 to once again reset the first timer.

As can thus be seen, the atrial defibrillator 30 provides bradycardiapacing of the right ventricle 12 and, upon each electrical activationbeing sensed at the right ventricle, determines the time interval sincethe first timer 64 was reset by either a sensed electrical activation ofthe right ventricle or a stimulating pulse being delivered to the rightventricle during bradycardia pacing. Hence, in determining the timeintervals, the sensed electrical activations of the right ventricle andthe delivery of a stimulating pacing pulse to the right ventricle areconsidered to be equivalent events in that each results in adepolarization of the right ventricle.

Referring now to FIG. 3, it illustrates the manner in which the atrialdefibrillator 30 may be implemented for enabling the atrial fibrillationdetector 82. This process begins at step 130 wherein the microprocessorfirst determines whether the right ventricle has been paced by the paceroutput 108. If the right ventricle has not been paced, the processorproceeds to step 132 to determine whether an R wave has been detected atthe right ventricle. If an R wave has not been detected at the rightventricle, the processor returns to step 130 to once again determinewhether the right ventricle has been paced. If the right ventricle hasbeen paced as determined in step 130 or if an R wave has been detectedat the right ventricle in step 132, the processor then proceeds to step134 to calculate an average time interval using the last 20 stored timeinterval values. This is performed by the average calculation stage 74of the microprocessor 62.

After calculating the average time interval over the last twenty storedvalues of the time interval, the processor then proceeds to step 136 tocalculate the standard deviation of the average time interval calculatedin step 134 for the last twenty stored values of the time interval. Thestandard deviation is calculated in the standard deviation calculationstage 76.

After calculating both the average time interval for the last twentystored values of the time interval and the standard deviation for theaverage time interval for the last twenty stored values of the timeinterval, the processor then proceeds to step 138 to determine if theaverage time interval calculated in step 134 is less than or equal to afirst predetermined time interval of, for example, 500 milliseconds. Ifthe average time interval calculated in step 134 is not less than orequal to 500 milliseconds, the processor then returns to step 130 toonce again determine whether the right ventricle has been paced.

If in step 138 the processor determines that the average time intervalcalculated in step 134 is less than or equal to 500 milliseconds, theprocessor then proceeds to step 140 to determine if the standarddeviation calculated in step 136 is greater than or equal to apredetermined standard deviation of, for example, twenty milliseconds.If the standard deviation calculated in step 136 is not greater than orequal to twenty milliseconds, the processor returns to step 130 to onceagain determine whether the right ventricle has been paced. However, ifthe standard deviation calculated in step 136 is greater than or equalto the predetermined standard deviation of, for example, twentymilliseconds, the processor then proceeds to step 142 to enable theatrial fibrillation detector. This step is performed through the enablestage 78 which enables the atrial fibrillation detector 82, theanalog-to-digital converter 60, and the third sense amplifier 54 over acontrol line 55. This causes the atrial fibrillation detector 82, theanalog-to-digital converter 60, and the third sense amplifier 54 to beactivated.

As can thus be seen by the implementation illustrated in FIG. 3, theatrial defibrillator 30 activates the atrial fibrillation detector 82,the analog-to-digital converter 60, and the third sense amplifier 54responsive to the determined time intervals, and preferably, the lasttwenty time intervals stored in the memory 92. This allows the atrialfibrillation detector 82, the analog-to-digital converter 60, and thethird sense amplifier 54 to be normally disabled to avoid excessiveconsumption of the battery 114. This is particularly important becausethe algorithms utilized in arrythmia detectors, such as fibrillationdetectors, consume considerable power and if left continuouslyenergized, would require frequent replacement of the defibrillators inwhich they are employed for the purpose of replacing the depletablepower sources, such as a battery.

The criteria utilized for activating the atrial fibrillation detector isboth the average heart rate and the variability of the heart rate. Byutilizing this criteria, the atrial fibrillation detector need only beactivated when there is a probability that atrial fibrillation ispresent to thus permit the atrial fibrillation detector, theanalog-to-digital converter 60, and the third sense amplifier 54 to benormally disabled for conserving the power of the depletable powersource.

Thus far, it will also be noted that only the right ventricle is beingsensed. Only electrical activations of the right ventricle are sensedfor either providing bradycardia pacing of the right ventricle or forenabling the atrial fibrillation detector. This assures that littlepower is consumed during the times in which neither bradycardia pacingis required or in which there is a low probability that atrialfibrillation is present in the heart.

In accordance with this preferred embodiment, the atrial fibrillationdetector 82, the analog-to-digital converter 60, and the third senseamplifier 54 may also be activated manually from external to thepatient's skin. This external activation may be accomplished by, forexample, the patient's physician sending suitable commands from theexternal controller 100. The commands would then be received by thereceiver/transmitter 102 and conveyed to the microprocessor 62 whichwould then, in response to the received command, activate the atrialfibrillation detector 82, the analog-to-digital converter 60, and thethird sense amplifier 54.

Referring now to FIG. 4, it illustrates the manner in which the atrialdefibrillator 30 may be implemented for detecting the occurrence ofatrial fibrillation in the heart and for enabling either the atrialdefibrillation output or the right ventricle marker output of the atrialdefibrillator.

This process begins at step 150 wherein the microprocessor resets thesecond timer 66. The processor then proceeds to step 152 to determinewhether atrial fibrillation is detected. Here it is assumed that theaverage time interval calculated in step 134 for the last twenty valuesof the stored time intervals was less than or equal to 500 millisecondsand that the standard deviation of the average time interval for thelast twenty stored values of the time intervals was greater than 20milliseconds as calculated in step 136 and determined in step 140 tocause the atrial fibrillation detector 82, the analog to digitalconverter 60, and the third sense amplifier 54 to be activated by thecontrol line 55. Atrial fibrillation may be detected by themicroprocessor through processing the digitized values of the atrialactivity provided by the analog to digital converter 60. As previouslymentioned, the atrial activity is sensed by the second electrode 44 andthird electrode 46 of the second lead 36 and the third sense amplifier54.

There are many algorithms known in the art for processing such data todetermine if fibrillation is present. One such algorithm is disclosed ina paper: Nitish V. Thakor, Yi-Sheng Zhu and Kong-Yan Pan, "VentricularTachycardia and Fibrillation Detection by a Sequential HypothesisTesting Algorithm," IEEE Transactions On Biomedical Engineering," Vol.37, No. 9, pp. 837-843, September 1990. Implementing such an algorithmby a microprocessor such as microprocessor 62 is well within the previewof one skilled in the art.

If in step 152 it is determined that atrial fibrillation is notcurrently taking place in the heart, the microprocessor then proceeds tostep 154 to determine whether the second timer 66 has expired. If thesecond timer has not expired, the processor returns to step 152 to againdetermine whether atrial fibrillation is currently taking place in theheart. If in step 154 it is determined that the second timer 66 hasexpired, the processor then proceeds to step 156 to disable the atrialfibrillation detector. This step is performed after a predeterminedexpiration time of the timer 66, which may be, for example, six seconds.

If the atrial defibrillator in step 152 determines that atrialfibrillation is currently present in the heart, the microprocessor thenproceeds to determine whether it is able to obtain a reliablesynchronizing pulse for synchronizing the delivery of the defibrillatingor cardioverting electrical energy to the atria. This begins in step 158where the atrial defibrillator microprocessor determines whether anelectrical activation has been detected in the right ventricle. If an Rwave has not been detected in the right ventricle, the microprocessorperforms a loop to once again determine at step 158 if an R wave hasbeen detected in the right ventricle. When an R wave is detected in theright ventricle, the microprocessor proceeds to step 160 to start thethird timer 68. After starting timer 68, the processor then proceeds tostep 162 to determine whether an R wave has been detected in the leftventricle. If an electrical activation has not been detected at the leftventricle, the microprocessor then returns to step 162 to once againdetermine whether an R wave has been detected at the left ventricle.When an R wave is detected at the left ventricle, the microprocessorthen proceeds to step 164 to stop the third timer 68. In so doing, thethird timer 68 will have the time from when the R wave was detected atthe right ventricle in step 158 and when the same R wave was detected atthe left ventricle in step 162.

The microprocessor then proceeds to step 166 to determine if the timebetween the detection of the electrical activation at the rightventricle and at the left ventricle is within a range of normal delaytimes between depolarization activation waves being sensed at the rightventricle and the left ventricle. The predetermined range may beestablished by programming the range into the memory 92 from theexternal controller, through the receiver/transmitter 102 and themicroprocessor 62. The normal delay times may, for example, range from 5milliseconds to 30 milliseconds. As a result, in step 166, themicroprocessor determines whether the time between the sensing of theelectrical activation and the right ventricle and in the left ventriclewas greater than 5 milliseconds and less then 30 milliseconds. If it wasnot, this is considered to be a negative test resulting in an unreliablesynchronizing detection. In this event, the microprocessor proceeds tostep 168 to increment the first counter 84. The microprocessor thenproceeds to step 170 to determine whether the count in the first counter84 is equal to a predetermined count, of, for example, five. If it isnot, the processor then resets the third timer 68 in step 172 andreturns to step 158 to detect another R wave at the right ventricle fordetecting whether a reliable synchronizing pulse may be detected. Whenthe count within the first counter 84 reaches the predetermined count offive, the processor then proceeds to step 174 to disable the atrialfibrillation detector 82. Both this step and step 156 may be performedby the disable stage 80 providing a disable signal over the control line55 for disabling the atrial fibrillation detector, the analog to digitalconverter 60, and the third sense amplifier 54.

As can be seen from the foregoing, the atrial defibrillator will go nofurther in its processing even though atrial fibrillation has beendetected if it is not assured that a reliable synchronization pulsecould be generated for synchronizing the delivery of the defibrillatingor cardioverting electrical energy to the atria in synchronism with anelectrical activation of the heart. This also, as will be seenhereinafter, negates the need for activating the charging circuit 110for charging the storage capacitor if a defibrillating pulse could notbe reliably applied in synchronism with an electrical activation of theheart to further conserve the depletable power source of the battery114.

In determining whether a reliable synchronization pulse can be derived,and as will be seen hereinafter, in providing a synchronization pulse,the atrial defibrillator first senses a depolarization activation waveat a first area of the heart and senses the same depolarizationactivation wave at a second area of the heart. In accordance with thispreferred embodiment, the first area of the heart is the right ventricleand the second area of the heart is the left ventricle. If theactivation wave at the right and left ventricle is detected coincidentlyas will be determined in step 166, or detected at times too far apart tobe considered a legitimate electrical activation wave, a synchronizationpulse will not be derived nor will such detection be considered apositive test of the ability to derive such a synchronization pulse. Theforegoing is based upon the fact electrical activation depolarizationwaves propagate across the heart so that the sensing of an electricalactivation at two different areas of the heart should occur at differenttimes while noise, which may be mistaken for an electrical activation,would be detected at both areas of the heart simultaneously. As aresult, the non-coincident sensing of an electrical activation at twodifferent areas of the heart such as at the right ventricle and the leftventricle provide a reliable indication that the sensed electricalactivation is a real or legitimate electrical activation and can berelied upon for deriving a reliable synchronization pulse forsynchronizing the delivery of a defibrillating or cardiovertingelectrical pulse to the atria in synchronism with an electricalactivation of the heart.

Referring again to FIG. 4, if in step 166 it is determined that therehas been non-coincident sensing of an electrical activation at the rightventricle and the left ventricle by determining that such sensingoccurred within a time greater than 5 milliseconds and less than 30milliseconds, the microprocessor proceeds to step 176 to reset the thirdtimer 68. After resetting timer 68, the microprocessor then determinesin step 178 if the atrial defibrillator is set in the defibrillatingmode. In performing this step, the microprocessor accesses the contentsof a known storage location in the mode selection portion 98 of memory92 to determine, for example, if that bit is set or not set. Forexample, if the bit is set this may be considered by the microprocessoras indicating that the atrial defibrillator is set in the defibrillatingmode. If the bit is not set, the microprocessor may consider this asindicating that the atrial defibrillator is in the right ventriclemarker mode and not the atrial defibrillating mode. Hence, if it isdetermined in step 178 that the atrial defibrillator is in the atrialdefibrillating mode, it will then in step 180 enable the charge deliveryand energy control stage 90. If the atrial defibrillator is not in theatrial defibrillating mode, the microprocessor will then enable the syncmarker controller 70 in step 182.

Referring now to FIG. 5, it illustrates the manner in which the atrialdefibrillator 30 may be implemented for providing marker sync pulses tothe right ventricle 12 of the heart 10. The foregoing assumes that instep 178, the microprocessor determined that the atrial defibrillatorwas in the marker pulse mode and has enabled the sync marker controller70.

This process begins at step 190 with the microprocessor resetting thethird timer 68. The microprocessor then proceeds to step 192 todetermine whether an R wave has been detected at the right ventricle. Ifan R wave has not been detected, the microprocessor continues todetermine whether an R wave has been detected at the right ventricleuntil an R wave is detected. When an R wave is detected at the rightventricle, the microprocessor then proceeds to step 194 to start thethird timer 68. It then advances to step 196 to determine whether the Rwave has been detected at the left ventricle. If the R wave has not beendetected at the left ventricle, the microprocessor continues todetermine whether an R wave has been detected at the left ventricle andwhen the R wave has been detected at the left ventricle, themicroprocessor then at step 198 stops the third timer 68. After stoppingtimer 68, the microprocessor then proceeds to step 200 to determine ifthe time between the sensing of the R wave at the right ventricle and atthe left ventricle occurred within a time greater than 5 millisecondsand less than 30 milliseconds. If it has not, the detected R wave isconsidered to be either noise or an unreliable detection and themicroprocessor returns to step 190 to reset the third timer 68. If,however, the microprocessor determines in step 200 that the R wave wasdetected at the right ventricle and the left ventricle within the normaldelay time range of 5 milliseconds and 30 milliseconds, themicroprocessor then proceeds to step 202 to pace the right ventriclewith a marker pulse. This step is performed by the sync detector 72providing a sync pulse to the sync marker controller 70 and the syncmarker controller 70 causing the pacer output 108 to pace the rightventricle.

After the right ventricle is paced with the marker pulse, themicroprocessor proceeds to step 204 to increment the second counter 86.The microprocessor then proceeds to step 206 to determine whether thesecond counter 86 has reached a predetermined count of, for example, 60marker pulses. If it has not, the microprocessor returns to step 190 toreset the third timer 68 and to detect another electrical activation ofthe heart for providing a synchronizing pulse. If the count in thesecond counter 86 has reached the predetermined number of marker pulsescounted, such as 60 pulses, the microprocessor then proceeds to step 208to disable the sync marker controller 70 and to terminate the provisionof the marker pulses to the right ventricle.

As can be seen by the foregoing, the atrial defibrillator 30 is arrangedto provide marker pulses to enable a physician to determine whetherproper operating parameters have been established within the atrialdefibrillator for reliably detecting electrical activations to providereliable synchronizing pulses. The marker pulses provided to the rightventricle are preferably of a relatively low energy, and of an energywhich is insufficient to cardiovert or defibrillate the heart but whichmay be sufficient for pacing the right ventricle of the heart. Forexample, the quantity of electrical energy utilized in each marker pulsemay have an energy in the range of 5 to 50 microjoules and preferably 25microjoules. Marker pulse energies of, for example, 25 microjoules,although being sufficient to pace the right ventricle of the heart,would not adversely affect normal heart rhythm in as much as the markerpulses are being provided in synchronism with detected electricalactivations of the heart and more particularly, reliably detectedactivations of the heart in accordance with the present invention. Themarker pulses, if applied in the range of energies noted above, willhave energies sufficient so as to be detected on an electrocardiogramgenerated externally to the skin of the patient by a physician in aknown manner.

Referring now to FIG. 6, it illustrates the manner in which the atrialdefibrillator 30 may be implemented for applying cardioverting ordefibrillating energy to the atria 16 and 18 of the heart 10. For thisdescription, it is assumed that in step 178 the microprocessordetermined that the atrial defibrillator was in the atrialdefibrillating mode and that the charge delivery and energy controlstage 90 had been activated by the microprocessor.

This process begins at step 210 with the charge delivery and energycontrol stage 90 providing over control line 111 an enable signal toenable the charger to charge the storage capacitor of the charger andstorage capacitor circuit 110. The microprocessor then proceeds to step212 to reset the third counter 88 which, as will be seen hereinafter, isutilized to count synchronizing pulses. The processor then proceeds tostep 214 to reset the third timer 68. After resetting the third timer68, the processor proceeds to step 216 to determine whether an R wavehas been detected at the right ventricle. If an R wave has not beendetected at the right ventricle, the microprocessor continues todetermine whether an R wave has been detected at the right ventricle andwhen one is detected, the microprocessor proceeds to step 218 to startthe third timer 68. After starting the third timer 68, themicroprocessor proceeds to step 220 to determine whether the R wave hasbeen detected at the left ventricle. If the R wave has not been detectedat the left ventricle, the processor continues to determine whether theR wave has been detected at the left ventricle and when it is detected,the microprocessor in step 222 stops the third timer 68. After stoppingthe third timer 68, the microprocessor then in step 224 determineswhether the detection of the R wave at the right ventricle and at theleft ventricle occurred within the normal range of delay times of fivemilliseconds to 30 milliseconds. If it had not been so detected, themicroprocessor then returns to step 212 to reset the third counter 88.If the R wave had been detected at the right ventricle and the leftventricle within the normal delay time, the microprocessor then proceedsto step 226 to increment the third counter 88. After incrementing thethird counter 88, the microprocessor determines in step 228 if the thirdcounter has reached a count of five. If it has not, the microprocessorreturns to step 214 to once again reset the third timer 68 for detectinganother electrical activation of the heart. When the third counterreaches a predetermined count of, for example, five counts, themicroprocessor then proceeds to step 230 for discharging the capacitorof circuit 110. The discharging of the capacitor is controlled by thedischarge circuit 112 and the discharge duration is determined by asignal carried on a control line 113 to control the duration of thedischarge and thus the quantity of electrical energy delivered to theatria of the heart. The defibrillating or cardioverting energy isdelivered between the second electrode 44 and the third electrode 46 ofthe second lead 36 to confine the cardioverting or defibrillating energyto the atria of the heart. The quantity of energy delivered to the atriafor cardioverting or defibrillating the atria may be in the range of 0.1to 3 joules. The actual quantity of defibrillating energy required willvary from patient to patient but, in the majority of the cases, willfall within the range of 0.1 to 3 joules.

After applying the defibrillating energy to the atria of the heart, themicroprocessor then proceeds to step 232 to disable the charge deliveryand energy control stage 90. Lastly, the microprocessor then proceeds tostep 234 to disable the atrial fibrillation detector 82.

From the foregoing, it can be seen that five consecutive reliablesynchronizing pulses must be provided by the sync detector 72 beforedefibrillating or cardioverting electrical energy is applied to theatria of the heart to assure reliable synchronization. Upon the fifthsynchronizing pulse, the defibrillating or cardioverting electricalenergy is then applied to the atria of the heart which will occur insynchronism with the last one of the predetermined number of electricalactivations detected by the sync detector 72. As a result, reliablesynchronization of the defibrillating or cardioverting electrical energywith a detected electrical activation of the heart will be assured.

Once the atrial fibrillation detector is disabled in step 234, theatrial defibrillator returns to once again determine the probability ofatrial fibrillation and, if there is a probability of atrialfibrillation, to once again enable the atrial fibrillation detector.This begins the implementation of the atrial defibrillator asillustrated in the flow diagrams of FIGS. 4-6.

Referring now to FIG. 7, it illustrates the intravascular second lead 36which is structured in accordance with another aspect of the presentinvention. As will be noted, the lead 36 includes the first or tipelectrode 42, the second or ring electrode 44, and the third electrode46. Hence, the second electrode is proximal to the tip electrode 42, andthe third electrode 46 is proximal to the second electrode 44 with thefirst electrode 42 being at the distal end of the lead.

The lead 36 also includes a connector 45 at its proximal end having afirst contact 42a, a second contact 44a, and a third contact 46a. Theconnector 45 is preferably arranged for being matingly received by acomplimentary receptacle of the enclosure 32 of the atrial defibrillator30. The lead 36 includes three conductors which are illustrated in FIG.8. Here it can be seen that the first conductor 42b, the secondconductor 44b, and the third conductor 46b are coaxially disposed to oneanother with the first conductor 42b being a center conductor, thesecond conductor 44b being an inner conductor, and the third conductor46b being an outer conductor. The conductors are arranged such that thefirst conductor 42b connects the first contact 42a with the firstelectrode 42, the second conductor 44b connects the first contact 44awith the second electrode 44, and the third conductor 46b connects thethird contact 46a with the third electrode 46. It will also be notedthat the lead 36, although being flexible, includes a preshaped portionand is preshaped to generally conform to the shape of the coronary sinusof the heart in which the lead is arranged to be advanced. Thepreshaping of the electrode in portion 47 assures that the distal end ortip electrode 42 will advance to within the coronary sinus adjacent theleft ventricle. As previously mentioned, when the first electrode iswithin the coronary sinus adjacent the left ventricle, the secondelectrode 44 is beneath the left atrium near the left ventricle and thethird electrode is within the right atrium or the superior vena cava.

From the foregoing, it can be seen that the present invention provides anew and improved fully implantable atrial defibrillator which is fullyautomatic. In addition, the atrial defibrillator of the presentinvention is arranged to conserve power to minimize the frequency inwhich a depletable power source must be replaced. In addition, theatrial defibrillator of the present invention assures reliablesynchronizing of the defibrillating or cardioverting electrical energyto the atria with sensed electrical activations in the heart. Further,the atrial defibrillator of the present invention provides a means bywhich the reliable generation of synchronizing pulses may be confirmed.All of the foregoing assures that an atrial defibrillator is providedwhich is safe in use and has an extended lifetime.

While a particular embodiment of the present invention has been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

What is claimed is:
 1. A lead for use in association with an atrialdefibrillator of the type arranged to cardiovert the atria of the humanheart, said lead comprising:a distal end and a proximal end, saidproximal end including connector means arranged to be received by saidatrial defibrillator, said connector means including first, second, andthird contacts; a first electrode at said distal end; a second electrodeproximal to said first electrode; a third electrode proximal to saidsecond electrode; conductor means for electrically connecting said firstcontact to said first electrode, said second contact to said secondelectrode, and said third contact to said third electrode; and said leadbeing flexible so as to be arranged to be passed down the superior venacava of the heart, into the right atrium, into the coronary sinusostium, and advanced into the coronary sinus or great cardiac vein ofthe heart near the left ventricle, and wherein said electrodes arespaced apart such that when said first electrode is within the greatcardiac vein adjacent the left ventricle, said second electrode iswithin the great cardiac vein or the coronary sinus adjacent the leftatrium.
 2. A lead as defined in claim 1 wherein said conductor means arecoaxially disposed with said first conductor being a center conductor,said second conductor being an inner conductor, and said third conductorforming an outer conductor.
 3. A lead as defined in claim 1 wherein thedistal end beyond said third electrode is preshaped to generally conformto the shape of the coronary sinus of the heart.
 4. A lead as defined inclaim 1 wherein said second and third electrodes are cardiovertingelectrodes.
 5. A lead for use in association with an atrialdefibrillator of the type arranged to cardiovert the atria of the humanheart, said lead comprising:a distal end and a proximal end; a firstcardioverting electrode; and a second cardioverting electrode proximalto said first electrode, said lead being flexible so as to be arrangedto be passed down the superior vena cava of the heart, into the rightatrium, into the coronary sinus ostium, and advanced into the coronarysinus or great cardiac vein, and wherein said electrodes are spacedapart such that when said first electrode is within the coronary sinusor great cardiac vein adjacent the left atrium, said second electrode iswithin the right atrium or the superior vena cava and wherein the distalend of said lead beyond said second electrode is preshaped to generallyconform to the shape of the coronary sinus of the heart.